FDA Adverse Event
Malfunction
Summary report: N
BIOSURE INSTRUMENTS
MDR report key: 4791730
·
Received May 22, 2015
Report
- Report Number
- 1219602-2015-00110
- Event Type
- Malfunction
- Date Received
- May 22, 2015
- Date of Event
- April 23, 2015
- Report Date
- April 23, 2015
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- NBH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
ALTHOUGH ANTICIPATED, THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. (B)(4).
Additional Manufacturer Narrative · 1
TWO DEVICES WERE RETURNED FOR EVALUATION. IT WAS CONFIRMED THAT THE PARTS ARE LASER MARKED WITH ¿NOT FOR HUMAN USE.¿ AS A RESULT OF THIS INCIDENT A CORRECTIVE AND PREVENTATIVE ACTION HAS BEEN INITIATED. THE ROOT CAUSE INVESTIGATION IS UNDERWAY. (B)(4).
Description of Event or Problem · 1
INCORRECT MARKING - THIS UNIT ARRIVED AT THE DISTRIBUTION CENTER AS MARKED - NOT FOR HUMAN USE. THE UNIT WAS SENT OUT TO A CUSTOMER BY A MATERIALS STAFF MEMBER AS THEY WERE NOT AWARE OF THIS WHEN IT SHIPPED. NO CASE, NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 337022 | BIOSURE INSTRUMENTS | BIOSURE RATCHET DRIVER | NBH | SMITH & NEPHEW, INC. | 72201888 | 50536704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |